Auxiliary transfer device



Dec. 16,1969 GHUEBNER ETAL 4 3,484,849

AUXILIARY TRANSFER DEVICE Filed June 30. 1967 2 Sheets- Shee4t 1 a a 8 sT1 I 4 i 4 n.

D 4 INVENTORS Gus/4 mm Haas v59 HEIPBGQ)" M450 2 16,1969 QHUEBNER ET AL3,484,849

V AUXILIARY TRANSFER rmvrcn Filed-M11630, 1967 z Sheets-Sheet 2INVENTORS Guam/5e fluaavcr Haven-Pr Mai v2 United States PatentAUXILIARY TRANSFER DEVICE Guenther Huebner, Stolberg, Rhineland, andHerbert Maenz, Heiligenhafen, Germany, assignors to 'Chemie GruenenthalG.m.b.H., Stolberg, Rhineland, Germany, a corporation of Germany FiledJune 30, 1967, Ser. No. 650,306 Claims priority, application Germany,July 2, 1966,

C ,7 Int. Cl. A61j 3/00, 1/00 US. Cl. 137-575 12 Claims ABSTRACT OF THEDISCLOSURE The present invention relates to an auxiliary device forpreparing sterile solutions.

In principle, sterile solutions intended for injection or infusion canbe prepared by two difierent methods. In the first of these two methods,the sterile solution is actually prepared by the manufacturer and issupplied to the physician in suitable receptacles. Unifortunately, thismethod is unsuitable for a number of substances, because, for instance,the active ingredient is not sufiiciently stable on storage in dissolvedform. In such instances, another method is used, in which the activesubstance is introduced in stirile form into a first container and thesterile solvent into a second container. The active ingredient may be inthe form of a solid, a liquid, or a solution. In this method the probleminvolved is to combine the sterile solvent with the active agent in sucha manner that a sterile solution results, i.e. that neither of thecomponents of the solution is able to come into contact with nonsterileinstruments or non-sterile air.

Heretofore, the problem of preparing a sterile solution of a solidsubstance has been solved, for instance, by aspirating into a syringeenough solvent to dissolve the solid, injecting the solvent into thecontainer containing the solid, thereafter reaspirating the resultingsolution into the syringe, and finally injecting it into a furtherquantity of solvent so as to provide a solution of the desired strength.This procedure is rather complicated and does not rule out the danger ofcontamination, because the syringe repeatedly comes into contact withthe air and the non-sterile outer surface of the stoppers used to closethe containers.

Furthermore, it has been proposed to arrange a transfer tube between thetwo containers, in which case additional air vents have to be providedto prevent the entrained air from blocking the transfer of liquid fromone container to the other. To overcome this drawback, it has beenproposed to provide the transfer tube with a flexible bulb which, actingas a kind of pump, enables the liquid to flow into one of the bottlesand the air to escape into the other bottle.

It is one object of the present invention to provide an auxiliary devicefor preparing sterile solutions by means of which it is possible totransfer from one bottle containing a sterile solvent into a secondbottle containing a sterile substance a quantity of solvent sufiicientto dissolve the sterile active substance present in the second bottleand then to return the solution thus obtained to the first bottle, whichdevice is free of the disadvantages of the prior art apparatus anddevices.

Other objects of the present invention and advantageous features thereofwill become apparent as the description proceeds.

In principle the auxiliary device for preparing sterile solutionsaccording to the present invention comprises a body member or blockhaving two bores, with a cannula inserted in each bore. The cannulaproject from different ends of the bores. The length of the cannulasprojecting from the bores are at least twice the distance between theends of the bores and the center of the body member or block.

The auxiliary device according to the present invention is illustrateddiagrammatically in the accompanying drawings, in which FIG. I is asection through one embodiment of the device;

FIGS. 11 and III are sections indicating important features of two otherembodiments of the invention;

FIGS. IVa, b, c, and d are plan views showing four embodiments of one ofthe features of the device;

FIGS. V and VI are sections illustrating the use of the device, and

FIG. VII shows a protective cap for the device.

Referring now to the drawings, one embodiment of the auxiliary deviceaccording to the invention is shown in FIG. I. The double-bored block 1is made of a sterilizable rigid material composed, for instance, ofpolystyrene, polyacrylonitrile, or similar plastics, or even of metal.Block 1 has one or more projections 2 acting as handles and at the sametime as stops for limiting the depth of penetration. The projections 2may be in the form of an encircling plate which, through it may 'becircular, is preferably in the shape of an ellipse, a rectangle, ahexagon, a triangle, a square or any other geometric form. Some examplesof the shape of plate 2 are shown in FIGS. IVaJ to d.

As mentioned hereinabove, block 1. is provided with two bores runningtherethrough. The first bore has an opening 6 at one end of the blockand the second bore has an opening 7 at the other end of the block.Cannula 3 is inserted into the second bore at the end distant fromopening 7 and cannula 4 is inserted into the first bore at the enddistant from opening 6. Cannula 3 has an opening 5, and cannula 4 has anopening 8.

The length of cannulas 3 and 4 is such that the distance A or,respectively, A between openings 5 and 6 or, respectively, 7 and 8 ofblock 1 and cannulas 3 and 4 is at least twice as large as the distanceB or, respectively, B between openings 6 and 7 of block 1 and itsmiddle. Distance A as preferably equal to distance A and distance B ispreferably equal to distance B.

As shown in FIG. I openings 6 and 7 and the openings 5 and 8 in block 1and cannulas 3 and 4 may be directed in pairs towards the same side.Alternatively, as shown in FIGS. II and III with respect to openings 7and 8, however, they may be turned away from one another (FIG. II) oroffset relative to one another, for instance, by (FIG. III).

FIGS. V and VI illustrate the use of the auxiliary device according tothe present invention in the preparation of sterile solutions. Forinstance, bottle 9 which is closed by stopper or rubber plate 11 held inposition by flanged cap 10, may contain the sterile solvent. The sterileactive substance may be accommodated in the form of a solid in bottle 12which is sealed by closure 14 held in position by flanged cap 13. Bottle12 may be so small that it is able to accommodate only the amount ofsolvent required to dissolve the active substance. To prepare a sterilesolution of said active substance, the

auxiliary device is pushed through closure 11 of bottle 9 and throughclosure 14 of bottle 12, as shown in FIG. V. Thereafter solvent flowsout of bottle 9 into opening 6 in block 1 and through opening 8 ofcannula 4 into bottle 12. The air present in bottle 12 may escapethrough opening 7 in block 1, passing into bottle 9 through opening 5 ofcannula 3.

After the active agent has ben dissolved in bottle 12 the unitcomprising bottles 9 and 12 and the auxiliary device according to thepresent invention is turned through 180, into the position shown in FIG.VI. The solution of active principle formed in bottle 12 then flowsthrough opening 7 in block 1 and through opening 5 of cannula 3 intobottle 9, while the air present in bottle 9 passes through openings 6and 8 back into bottle 12.

This advantageous mode of operation of the novel auxiliary deviceresults in particular from the aforementioned ratios between thedistances A and B and between the distances A and B. In the arrangementof bottles 9 and 12 and of the auxiliary device as shown in FIGS. V andVI, an adequate difference in pressure exists in the liquid betweenopenings 5 and 6 (FIG. V) and 7 and 8 (FIG. VI). This difference inpressure allows the air in the lower bottle to pass into the upperbottle, and to allow the liquid in the upper bottle to flow down intothe lower bottle.

Accordingly, it is possible, by means of the auxiliary device accordingto the present invention, to add a predetermined quantity of solvent toan active substance under sterile conditions and to return the resultingsolution to the major quantity of solvent safely and in a simple mannerwithout any need to ventilate either of the bottles by means of cannulascommunicating with the surrounding air, or to transfer mechanically thesolvent and solution by pumping.

The auxiliary device according to the present invention is easy tosterilize, whereby the sterilizing conditions are governed in particularby the type of material used for block 1. If block 1 is made of amaterial which would undergo deformation if sterilization were to becarried out in the usual manner by means of steam under pressure, theauxiliary device can be sterilized very readily, for instance, bytreating it with ethylene oxide, even at relatively low temperatures.

In order to maintain the sterility of, in particular, those parts of thedevice which will come into contact with the sterile solvent or activesubstance accommodated in bottles 9 and 12, cannulas 3 and 4 and bores 6and 7 of block 1 are preferably covered by protective caps. One suchprotective cap is provided to cover cannula 3 and opening 6 and anotherone to cover cannula 4 and opening 7. This is shown in FIG. VII in whichprotective cap 15 covers cannula 4 and opening 7.

The device according to the present invention may, of course, be usednot only for the preparation of sterile solutions of drugs and otheractive agents, but also for the preparation of sterile solutions ofactive agents to be used for intravenous infusion. The device may alsobe used for technical purposes, for instance, for preparing solutions ofoxygen-sensitive compounds and agents, whereby the bottles may be filledwith an inert gas, for chemical reactions which are highly sensitive tooxygen, carbon dioxide, or other gases, whereby the containers arefilled with an inert gas, and for other purposes requiring protection ofthe contents against the influence of microorganisms and gaseouschemical agents.

We claim:

1. An auxiliary device for preparing sterile solutions by transferring aliquid from one container to another container containing a solid orliquid substance with which the device is adapted to be connected, whichdevice comprises a block having a first and a second bore, the firstbore having an opening at one end of the block adapted to be inserted inone container and the second bore having an opening at the opposite endof the block adapted to be inserted in the other container, a cannulainserted into each bore, the cannulas projecting from different ends ofthe bores, each cannula being at opposite ends of said respectiveopenings and providing a second opening in the respective container, theblock with the two bores and their respective cannula therebyestablishing a dual conduit between the two containers with which thedevice is adapted to be connected, and the length of the cannulasprojecting from the bores being at least twice the distance between theends of the bores and the center of the block.

2. The auxiliary device as claimed in claim 1, wherein the block has atleast one projection around its middle.

3. The auxiliary device as claimed in claim 2, wherein the projectionsare in the form of a plate encircling the block.

4. The auxiliary device as claimed in claim 3, wherein the projectionsare in the shape of a rectangle encircling the block.

5. The auxiliary device as claimed in claim 3, wherein the projectionsare in the shape of a hexagon encircling the block.

6. The auxiliary device as claimed in claim 3, wherein the projectionsare in the shape of an ellipse encircling the block.

7. The auxiliary device as claimed in claim 1, wherein the lengths ofthe cannulas projecting from the block are equal to each other.

8. The auxiliary device as claimed in claim 1, wherein the distancesfrom the ends of the bores to the middle of the block are equal to eachother.

9. The auxiliary device as claimed in claim 1, wherein the cannula andthe ends of the bores in the block are covered by a protective cap.

10. The auxiliary device as claimed in claim 9, wherein one protectivecap is used to cover one cannula and the end of one bore, and a secondcap is used to cover the other cannula and the end of the other bore.

11. The auxiliary device as claimed in claim 1 wherein the block has twoprotruding ends, each one of which is adapted to project into therespective containers.

12. The auxiliary device as claimed in claim 1 wherein the endprojecting into the bottle of each cannula is sharpened.

References Cited UNITED STATES PATENTS 2,202,163 5/1940 Mulford et al.137575 X 2,884,924 5/1959 Shaw 137588 X 2,973,758 3/1961 Murrish l28-2723,366,278 1/1968 Fobes 128272 X M. CARY NELSON, Primary Examiner WILLIAMR. CLINE, Assistant Examiner US. 'Cl. X.R. 128272

